Question 1

What is CompliRx?

Accepted Answer

CompliRx is a digital compliance platform built for 503A and 503B compounding pharmacies. It replaces paper logs, spreadsheet tracking, and manual monitoring with real-time environmental monitoring, digital SOP management, automated training tracking, and inspection readiness tools, in one connected system.

Question 2

Who is CompliRx for?

Accepted Answer

CompliRx is designed for compounding pharmacy owners, quality assurance directors, pharmacy managers, and compliance officers at 503A, 503B, and veterinary compounding facilities.

Question 3

How much does the CompliRx pilot cost?

Accepted Answer

The 90-day CompliRx pilot costs $399 per month and includes full platform access, guided onboarding, sensor integration support, and direct workflow review.

Question 4

Does CompliRx meet 21 CFR Part 11 requirements?

Accepted Answer

Yes. CompliRx includes password re-authentication at signing, SHA-256 signature hashing, complete audit trails (who, what, when, why), user agent and IP logging, and follows ALCOA+ principles for data integrity.

Question 5

What USP chapters does CompliRx cover?

Accepted Answer

CompliRx covers USP <797> (sterile compounding), USP <795> (non-sterile compounding), and USP <800> (hazardous drugs). Environmental monitoring, personnel competency tracking, and cleaning documentation are all built to these standards.

Question 6

Can CompliRx help us prepare for FDA inspections?

Accepted Answer

Absolutely. CompliRx includes a compliance scoring system, inspector view mode, mock inspection checklists, Form 483 tracking, and a document index, all designed to keep you inspection-ready.

Question 7

What does the 90-day pilot include?

Accepted Answer

For $399 per month, pilot facilities receive full platform access including environmental monitoring, SOP management, training tracking, compliance scoring, and inspection readiness tools. The pilot also includes sensor integration support, priority data migration assistance, and guided onboarding.

Question 8

What environmental sensors are supported?

Accepted Answer

CompliRx integrates with SafetyCulture (iAuditor), Monnit, SensorPush, and Dickson sensors. We also support CSV imports for any sensor system.

Question 9

Does CompliRx connect to my LIMS?

Accepted Answer

CompliRx supports bulk LIMS import for microbial monitoring data. We also provide a REST API with ~48 endpoints for custom integrations.

Question 10

Where is my data stored?

Accepted Answer

All data is stored in Supabase (PostgreSQL) with row-level security policies enforcing strict tenant isolation. Infrastructure is hosted on AWS with SOC 2 compliant providers.

Question 11

Is my data encrypted?

Accepted Answer

Yes. Data is encrypted at rest and in transit. All API communications use TLS 1.2+. Database connections use SSL.

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